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LFB
Création	1er juin 1994 law 93.5 of 4 janvier 1993
Dates clés	1994 Establishment - French Law of 4 january 1993 about blood transfusion security and medical products, 2006 Creation of LFB SA.
Personnages clés	Christian Béchon, CEO of LFB SA.
Forme juridique	Société anonyme à Conseil d'administration
Slogan	"Ethical commitment."
Siège social	Les Ulis France (3, Avenue des Tropiques 91158)
Actionnaires	État Français 100 %
Activité	Fractionation of plasma proteins - Medicinal products for the treatment of blood diseases. R&D in Biotechnologies.
Filiales	LFB Biomédicaments, LFB Biotechnologies, LFB Biomanufacturing en France, CELLforCURE, LFB Hemoderivados e biotecnologia (Brésil), LFB Biopharmaceuticals Co Ltd. (Angleterre) et LFB GmbH (Allemagne), CAF-DCF (Belgique).
Site web	lfb.fr
Capitalisation	N/D

LFB is a French public laboratory which specialises in the fractionation of plasma proteins extracted from human blood plasma. It is the only laboratory allowed to fractionate plasma from voluntary blood donors collected throughout France by the Etablissement Français du Sang (EFS - French Blood Institute). LFB is a major global player in the plasma fractionation industry and in the manufacture of therapeutic proteins. It extracts a very wide range of medicinal products from plasma which are available on hospital prescription and indicated for some 80 severe and often rare diseases in the fields of haemostasis, immunology and for intensive care purposes. LFB is also developing tailored services and making technology transfers to other countries, particularly Brazil. LFB is the 3rd most important hospital laboratory in France. LFB is also a major European company in the biotechnology industry.

Establishment

Until 1993, plasma products and derivatives were produced directly by blood transfusion centres since these were considered to be blood derivatives. The French Law of 4 January 1993 , separated these activities by classifying plasma proteins and derivatives as medicinal products subject to control by the ANSM (Agence Nationale de Sécurité des Médicaments et des produits de santé - French National Agency for the Safety of Medicines and Healthcare Products) which have to be approved before being placed on the market. On the 24 January 1994 the convention establishing LPB as a Groupement d'Intérêt Public (GIP) or Public Interest Group was laid down and on the 19 March 1994 this was approved by government order. The GIP was formally established on the 1st June 1994. The Head Office is located at 37 rue Violet, 75015 Paris, France.

Constitution

LFB became a public limited company in July 2006 with 100% of its capital held by the French Government. In September 2006, two subsidiaries were created: LFB Biomedicaments and LFB Biotechnologies.

LFB, Public Limited Company

To comply with the modernisation law of 8 June 2004 , LFB was converted from a GIP into a private-sector public limited company and subsidiaries were created to separate its fractionation activities from R&D. Ordonnance 2005-866 of 28 July 2005 was published in the Official Journal of the French Republic (JORF) on 28 July 2005 converting the Public Interest Group called “Laboratoire français du fractionnement et des biotechnologies” (French Laboratory for Fractionation and Biotechnologies) into a public limited company .

Article L.5124-14 of the French Code of Public Health as amended by Ordonnance 2005-866 of 28 July 2005 Article 3 (JORF 29 July 2005).

• [...] “Any legal entity whose purpose is to collect blood or its components cannot hold a direct or indirect shareholding in the public limited company “Laboratoire français du fractionnement et des biotechnologies” or in the companies controlled by LFB as defined by Article L.233-3 of the French Commercial Code”.
• “The company “Laboratoire français du fractionnement et des biotechnologies” and companies controlled by it as defined by Article L.233-3 of the French Commercial Code cannot hold a direct or indirect shareholding in a legal entity whose purpose is the collection of blood or its components”.

As such blood establishments which were previously a part of the GIP were divested and the French Government became the sole shareholder. LFB SA was formally established on the 7th July 2006. In time the capital may be opened to other investors but it will have to remain under the majority control of the French Government or its public establishments.

VOTE OF THE HPST LAW: The Public Health Function of LFB written into law. Adopted by both Houses of the French National Assembly at the beginning of June and enacted in July 2009, Article 21 (5) of the HPST Law includes an important measure for LFB Biomedicaments and the supply of medicines derived from the plasma of French patients. LFB is legally obliged to prioritise the national market from plasma collected by the Établissement Français du Sang (EFS – French Blood Institute). The law also affirms the involvement of LFB in the “treatment of rare diseases”. Article 21 (5) of the HPST Law defines the obligations of LFB as follows:

• “This subsidiary will prioritise the fractionation of plasma from blood or its components collected by the French Blood Institute. To meet national requirements, in particular those to do with the treatment of rare diseases, it will prioritise the distribution of medicinal products produced from these procedures within France”*. There is therefore a double priority. First of all, the plasma given to LFB by the EFS must be processed first before any other plasma and secondly priority must be given to distributing the medicines derived from this within France. The law also recognises LFB’s work in treating rare diseases which sometimes only affect a few dozen patients.

Article 21 (5) maintains the regulations which applied previously as to the public service nature of LFB SA and LFB Biomedicaments with the French Government as the majority shareholder.

Board of Directors

The group executive committee has been chaired by Christian Béchon since 2005 and consists of 19 people, 6 of them representatives of the French Government. :

Board of Directors

Qualified Persons

Name	Title
René Abate	Deputy Director Delphen SARL - Senior Advisor BCG – Board Member Carrefour SA and Atos Origin
Christian Béchon	CEO of LFB SA
Docteur Élisabeth Hubert	Director of Aliagis – President of HAD France – Board Member LFB Biotechnologies
Francis Mer	Chairman of Supervisory Board of Safran
Jean StéphenneJean Stéphenne	CEO GSK Vaccines - GSK Biologicals
Jean-Marie Zacharie	CEO of Shigamedix - Paris Biotech Santé

Government Representatives

Name	Title
François Auvigne	Inspector General of Finance – Ministry of the Economy, Finance and Industry.
Christian Estève	Special Advisor to the Director General for research and innovation in the Department for enterprise, technology transfer and regional development.
Marie-Christine Favrot	Evaluation Director for health and nutritional risks – ANSES (National Agency for Food, Environmental and Occupational Health Safety) – Ministry of Work, Employment and Health
Thomas Gosset	Ingénieur de l'armement, Head of EDF Office and other Shareholdings – Government Shareholdings Agency
Cécile Tharaud	Chairman of the Executive Board – INSERM Transfert
Daniel Vasmant	Head of Health Office – Biotechnology, Agricultural Industry at the Ministry of Industrial Regeneration

Staff Representatives

Name	Title
Vincent Denois	Manager infrastructure and operations – Information Systems Department.
Frédéric Dhainaut	Manager animal physiology laboratory – Department of pre-clinical development.
Nicolas Herman	Deputy production manager – Industrial Division
Marc Lascombes	Manager for industrial development projects – Industrial Division
Hervé Marcilly	R&D Division – QA Manager
Dominique Saint Picq	Head of Organisation and Planning Dept. for Ulis site laboratories – Dept. of Inspection Laboratories.

Fractionation Exclusivity

Article L.5124-14 of the French Code of Public Health authorises LFB Biomédicaments, the LFB subsidiary responsible for fractionating plasma, to produce medicinal products from blood or its components collected by the French Blood Institute.

The French blood donor system – the “General System”

The General System is a procedure for ensuring safety. It enables the quality of plasma to be monitored at all times. It consists of 11 main points and 5 subsidiary points.

Medical selection of donor

In accordance with French ethical criteria: unpaid, anonymous, volunteered, information given before they donate, health questionnaire, medical session, examination, information given after the donation and donor follow-up.

Blood Donation

Compliance with good transfusion practice such as sterile equipment and so forth. Correct identification of donations, destruction of spoiled material.

Insoection of donations

Laboratory testing to ensure absence of disease.

Preparation, deleucocytation, freezing

After preparation and deleucocytation the plasma is frozen at about -40 °C to ensure good preservation. It will keep for a year after which is has to be destroyed.

Arrival at laboratory

Plasma is transported from EFS in a refrigerated truck by an LFB mandated carrier. Collections are carried out at EFS technical facilities throughout France. Shipment conditions and temperatures are recorded and checked as well as the documentation. Each incoming batch is identified and registered with an ID number and the date of receipt. Each donation number is recorded for traceability purposes. The detachable tube on the bag containing blood plasma is used to check that various diseases are not present.

Quality Control

Batches are recorded and quarantined. The laboratory carries out virology checks on bags to confirm that no diseases are present.

Quarantine before fractionation

All bags suitable for fractionation after laboratory testing are quarantined for 50 days before being used. The total quarantine time is 90 days.

Inspection before fractionation

Batches are released from quarantine and sent for production. The uniform mixture of a batch of plasma ready for fractionating then undergoes a battery of tests. If these are negative the batch is declared fit for fractionation. Otherwise it is incinerated.

Special Safety Procedures

Purification, viral inactivation and nanofiltration are used to eliminate or inactivate any viruses in the plasma before it is turned into finished products.

Medicinal Product Inspection

Each batch of medicinal products is inspected before sale using special procedures in accordance with the specification under which it was granted a product licence.

Prescription, dispensing

The finished product is made available and can be prescribed and used by patients.

The 5 additional points are:

• Traceability, haemovigilance, pharmacovigilance, quality assurance program and quality audit. The laboratory is involved in all these procedures and performs them in accordance with applicable legislation and ANSM recommendations.

Products

LFB manufactures and sells a range of medicinal products in three major therapeutic fields:

Haemostasis

• BETAFACT® - (Human coagulation factor IX).
• FACTANE® - (Human coagulation factor VIII).
• WILFACTIN® - (Human von Willebrand factor).
• WILSTART® - (Human von Willebrand Factor and coagulation Factor VIII).
• HEMOLEVEN® - (Human coagulation factor XI).
• ALFALASTIN® - (Human Alpha 1-antitrypsin).

Intensive Care

• ACLOTINE® - (Human Antithrombin)
• VIALEBEX® - (Human Albumin)
• CLOTTAFACT® - (Human Fibrinogen)
• KANOKAD® - (Human prothrombin complex - PPSB)
• PROTEXEL® - (Human Protein C).
• GAMMATETANOS® - (Human tetanus immunoglobulin)
• IVHEBEX® - (Human hepatitis B IV immunoglobulin)
• Ig HEPATITE B IM - LFB® - (Human hepatitis B IM immunoglobulin)
• ATRYN® – (Antithrombin (recombinant))

In France LFB Biomédicaments sells the synthetic medicinal product ARGANOVA® (agratroban monohydraté). The product licence belongs to Mitsubishi Pharma Europe.

Immunology

• TEGELINE® - (Normal human immunoglobulin IV).
• CLAIRYG® - (Normal human immunoglobulin IV).

In Figures

1. 1. Each year several hundred thousand patients are treated with LFB medicinal products. ;
2. 22 medicinal products

Facilities

In addition to the head office located in Les Ulis in the Essonne region of France, LFB has five production facilities.

• Les Ulis, Production site that specialises in the processes that take place prior to plasma fractionation; cellular therapy medicinal product manufacturing facility - CELLforCURE.;
• Lille, production facility that specialises in post-fractionation procedures ;
• Carvin, Central and pharmaceutical warehouses  ;
• Loos-lez-Lille, Biotech research centre in the Eurasanté science park which has a bio-incubator ;
• Paris, Offices ;
• Ales, Bioproduction site that specialises in cell culturing - LFB Biomanufacturing;
• Framingham (MA, USA) – Facility for research and production of lacto-recombinant medicinal products - rEVO Biologics Inc.

G5

LFB is a member of G5, a group of 5 French pharmaceutical and advanced research organisations. The aim of the group is to maintain their decision making centres in France. All member companies make research “their priority”. The founding values of the group are based around 9 themes, 5 in the founding charter and 4 in the aims and activities.

• Founding Charter :
  • To have member pharmaceutical companies recognised as natural partners for the authorities in terms of health independence and promotion of the public health objectives defined by the Government.
  • To have the founding members recognised as essential research organisations in France, already strongly contributing to the development of public laboratories.
  • To have the innovation capability of these companies recognised and to have their development recognised as a strategic priority.
  • To have the consequences of medicinal product policy evaluated and taken into account in industrial terms and the attractiveness of the French market.
  • To promote a policy of just care at the right price by ensuring that innovations and medicinal products of proven therapeutic value are remunerated in a fair way.

• • Aims and Activities :
  • Health independence.
  • Research excellence.
  • French innovation.
  • International recognition.

Links

• G5, group of pharmaceutical and advanced research organisations
• LFB website
• LFB Biomanufacturing website
• CELLforCURE website